Decorative Contact Lenses Under U.S. FDA Jurisdiction

FDA issues warning on dangers of decorative contact lenses

MONDAY, Oct. 30 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning about the serious risks of using decorative contact lenses and notes that since an amendment to the Food, Drug and Cosmetic Act in November 2005, all contact lenses are considered medical devices under the FDA's jurisdiction.

"Contact lenses distributed without appropriate involvement by eye care professionals are now considered misbranded devices under the law," according to an FDA statement. "FDA will aggressively use the full range of its statutory authorities to prevent the improper distribution of these potentially dangerous products."

Direct-to-consumer marketing and distributing of decorative contact lens without a prescription may increase during the Halloween season. However, such non-corrective lenses, also called Plano lenses, have been found to carry the same risks of corrective lenses including conjunctivitis, corneal ulcers, corneal abrasion and vision impairment or blindness, according to the FDA. In particular, decorative lenses have been linked to corneal ulcers when worn overnight.

Problems with decorative lenses can be reported to local FDA offices. Adverse and/or quality problems should also be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md., 20852-9787, or at the MedWatch Web site: www.fda.gov/medwatch.

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